With an investment of $2.2 billion, Johnson & Johnson is doubling down on the tumor surgical robot.

A bidding war involving multiple medical technology giants has finally come to an end.

Recently, a consortium composed of more than a dozen institutions, including K5 Global, JJDC (the venture capital arm of Johnson & Johnson), Bezos Expeditions (Jeff Bezos' personal investment company), and Wellington Management, made a lightning - fast acquisition of a majority stake in HistoSonics, a non - invasive tumor ablation robot enterprise, for $2.25 billion (approximately RMB 16.1 billion).

Earlier this year, news reports indicated that a consortium composed of giants such as Medtronic and GE Healthcare had offered $2.5 billion to acquire HistoSonics. Ultimately, the company, which was hotly contested by multiple giants, ended up in the hands of Johnson & Johnson, which had invested in HistoSonics multiple times during its financing stages.

This acquisition reveals another strategic move by Johnson & Johnson in the field of surgical robots. In 2019, Johnson & Johnson acquired Auris Health, a laparoscopic surgical robot company, for a cash consideration of $3.4 billion, plus milestone payments of up to $2.35 billion. This current acquisition represents another bet on tumor ablation surgical robots.

The number of diseases covered by tumor interventional ablation robots is large, and there is significant potential for market penetration. According to the prospectus of Bard Medical, in 2021, the number of tumor ablation surgeries in China exceeded 300,000, and the global number of tumor interventional ablation surgeries is expected to be even larger. Additionally, the use of interventional ablation surgeries for benign nodules such as thyroid nodules and breast nodules is also growing rapidly.

With the support of a powerful consortium, the development of tumor ablation surgical robots is expected to accelerate, and the market share of high - intensity focused ultrasound (HIFU) in global tumor ablation is likely to increase.

Schematic diagram of HistoSonics' products

How valuable is the company that multiple giants are vying for?

In the medical field, surgeons have always faced a daunting challenge: how to remove the lesion while preserving normal tissue to the greatest extent possible. This is not only crucial for patients' recovery but also the ultimate goal of surgical procedures. The emergence of HistoSonics has brought a breakthrough solution to this problem, which is why it has been hotly contested by multiple giants.

HistoSonics has attracted multiple giants due to two core competencies: high - intensity focused ultrasound (HIFU) technology and an advanced robotic platform. The combination of these two technologies enhances the precision of tumor ablation, a minimally invasive technique, and is expected to expand the application of HIFU technology in diseases such as liver cancer, kidney cancer, and prostate cancer.

Key milestones in the development of HistoSonics

High - intensity focused ultrasound technology is not a new concept; it has long been an important method in tumor interventional therapy. Currently, common ablation methods include radiofrequency ablation (RFA), microwave ablation, ethanol injection therapy, cryoablation, laser ablation, and irreversible electroporation. In China, HIFU is not the mainstream method in tumor interventional ablation, while RFA and microwave ablation are more widely used, accounting for over 70% of the market.

The core principle of HIFU technology is to use the directionality, tissue penetration, and focusability of ultrasound waves to concentrate the ultrasound at a focal point, precisely destroying the diseased tissue while protecting the surrounding normal tissue to the greatest extent. Compared with traditional ablation methods, the main advantage of HIFU technology is that it causes little to no damage to the tissue around the target area.

HistoSonics induces a "bubble cloud" from the naturally occurring gas in the target tissue by focusing high - amplitude, extremely short pulsed sound waves. In a liquid, the high energy of the ultrasound causes the formation of tiny bubbles. These bubbles rapidly expand and contract under the pressure of the ultrasound and eventually collapse. When the cavitation bubbles collapse, they generate extremely high local pressure and temperature, creating powerful shockwaves and micro - jets. These shockwaves and micro - jets cause mechanical damage to the surrounding cell membranes and organelles, leading to the destruction and death of cell structures.

HistoSonics claims that its HIFU technology, Histotripsy, mechanically destroys tissue by using short, high - amplitude pulses. This method can precisely control the scope of destruction and avoid thermal damage to the surrounding healthy tissue, which is different from traditional HIFU technology.

However, some industry insiders believe that the cavitation effect inevitably brings about a thermal effect, which is not much different from traditional HIFU technology.

In 2023, HistoSonics' Edison Histotripsy system received de novo approval from the US FDA for non - invasive treatment of liver tumors and their metastatic lesions. Liver cancer is a major global health issue. The incidence of hepatocellular carcinoma (HCC) is increasing year by year, with approximately 840,000 new cases and 780,000 deaths annually. The non - invasive treatment provided by the Edison Histotripsy system offers a new solution for early - stage liver cancer treatment.

In China, HIFU technology has been widely and maturely applied. The main players include HIFU Medical and Shende Medical. The indications for HIFU Medical's HIFU knife include uterine fibroids, adenomyosis, placenta accreta, breast cancer, breast fibroids, primary liver cancer, metastatic liver cancer, pancreatic cancer, soft tissue tumors, primary bone tumors, metastatic bone tumors, renal cell carcinoma, benign kidney tumors, prostate cancer, and benign prostatic hyperplasia. In clinical practice, focused ultrasound ablation technology is also used to treat diseases such as cesarean scar pregnancy and abdominal wall incision endometriosis. Current clinical evidence shows that focused ultrasound ablation is a safe and effective treatment for these benign gynecological diseases.

The robotic platform enhances precision

HistoSonics' second major advantage is its robotic platform, which enables real - time imaging and robotic control, improving the precision of tumor ablation.

In the medical field, an ideal ablation technique should have key characteristics such as precise and controllable scope, small error, and minimal damage to surrounding tissue. However, traditional ablation techniques often face challenges when dealing with complex tumors due to inaccurate puncture positioning: difficult ultrasound - guided positioning, difficult evaluation of treatment effects, and difficult bleeding control.

One of the major challenges in the tumor interventional ablation field where HistoSonics operates is the issue of puncture positioning precision. In traditional minimally invasive percutaneous interventional ablation surgeries for liver cancer, doctors perform ablation treatment on tumor tissue through percutaneous puncture under the guidance of ultrasound, CT, or MRI, inducing tumor cell necrosis and local inactivation of the tumor tissue. However, they often encounter difficulties in identifying the tumor and precisely designing and controlling the puncture path.

Low precision in positioning and ablation not only easily damages surrounding tissue but also increases the risk of tumor recurrence. A study by West China Hospital of Sichuan University has confirmed that for hepatocellular carcinoma (HCC) that meets the Milan criteria, surgical resection has a higher long - term survival rate and a lower recurrence rate than radiofrequency ablation (RFA). Even for HCC patients with tumors less than 2 cm in diameter (the group with the best RFA treatment results), surgical resection has better survival and recurrence rates than RFA. Especially when HCC is located in special areas such as the liver surface, near large blood vessels and bile ducts in the liver, close to the diaphragm, gallbladder, and gastrointestinal tract, RFA often fails to achieve complete treatment due to concerns about complications, resulting in a higher recurrence rate. This is why minimally invasive ablation treatment has not replaced liver resection as the preferred method for radical treatment of HCC.

HistoSonics' robotic platform, the Edison platform, integrates a robotic arm, an ultrasound probe, an imaging display screen, and a control panel to monitor tissue destruction under continuous real - time visualization and control. The built - in microcomputer can process images in real - time and precisely control the movement of the robotic arm, enabling precise positioning and treatment. During the treatment process, Histotripsy is guided by real - time imaging technology (such as ultrasound imaging or MRI) to ensure that the ultrasound focus is accurately positioned on the tumor tissue. Real - time imaging not only helps with precise positioning but also monitors the treatment effect to ensure that the tumor tissue is completely destroyed while protecting the surrounding healthy tissue.

According to clinical data, HistoSonics' technology platform has performed excellently. At the beginning of this year, the company announced that its clinical trials covered 47 patients, including those with primary liver cancer and liver metastases. The data showed that 90% of the patients achieved local tumor control one year after treatment. All enrolled patients had previously tried standard treatments such as surgery, radiotherapy, or ablation, or were deemed ineligible for these treatments due to their physical conditions.

From a commercial perspective, HistoSonics has also performed impressively. The company said that more than 2,000 patients have been treated with the Edison system at over 50 centers in the United States, and it plans to install 50 more devices by the end of this year. This rapid market penetration not only reflects the clinical value of HistoSonics' technology but also demonstrates its strong competitiveness in the market.

In China, many enterprises are also actively exploring the development of percutaneous puncture robots. Puncture robots assist doctors in performing puncture surgeries through technologies such as three - dimensional reconstruction of medical images, puncture path planning, and robotic navigation and positioning, significantly improving the precision and safety of surgeries.

In the field of liver cancer, Jupiter - Intelligent Soft Tissue Puncture Interventional Navigation Surgical Robot launched by Beijing Aoda Zhisheng combines ultrasound navigation and millimeter - level precise puncture perfectly. The AI - enabled percutaneous puncture surgical navigation robot approved by Zhuoye Medical is suitable for minimally invasive interventional surgeries such as percutaneous puncture biopsy, ablation treatment, and particle implantation for solid tumors in the lungs and abdomen (such as lung cancer and liver cancer).

What are the challenges in commercialization?

The combination of high - intensity focused ultrasound technology and the surgical robot platform has rejuvenated and become a major breakthrough in the field of surgical procedures. However, to achieve wide - scale clinical application of this technology, many challenges remain. These challenges involve not only the technical level but also multiple dimensions such as clinical practice, industrial transformation, and commercial operation.

To gain wider clinical acceptance, high - intensity focused ultrasound technology still requires more high - level clinical evidence. In the field of tumor treatment, especially in the treatment of hepatocellular carcinoma (HCC), doctors will not ignore the principle of radical tumor treatment just because of the minimally invasive nature of the technology. The effectiveness, safety, and long - term benefits of HIFU treatment for tumors still need to be verified through large - scale, multi - center, long - term follow - up clinical studies.

New technologies often require a long period of technology promotion from the laboratory to the clinic and then to wide - scale promotion. The combination of high - intensity focused ultrasound technology and the surgical robot platform is no exception. In this process, what needs to be overcome is not only the maturity of the technology itself but also the establishment of standards, payment systems, and clinical training systems.

An industry insider pointed out that although significant progress has been made in technology accumulation at home and abroad, the most challenging part in technology promotion involves commercial operation, medical insurance payment, and the construction of subsequent systems.

The automation and minimally invasive nature of surgical procedures are the development trends. The development history of HistoSonics suggests the potential of cross - innovation and integration of technologies. The combination of high - intensity focused ultrasound and ultrasound - guided visualization brings new technological innovation to tumor ablation surgeries.

References

• Aoda Zhisheng breaks through the medical barriers with its self - developed puncture navigation robot by implementing ultrasound navigation and millimeter - level precise puncture - Arterynet

• Histotripsy treatment for liver cancer - Interventional Information

• Chen Zheyu | Advantages and disadvantages of radiofrequency ablation for hepatocellular carcinoma - Chinese Journal of General Surgery Basics and Clinics

This article is from the WeChat official account "Arterynet" (ID: vcbeat), author: Yang Xue. Republished by 36Kr with permission.